This "StarLink event" is helping to create a climate in which
biotechnology companies increasingly feel compelled to convince the public that food
from transgenic plants is essentially identical to that from traditional crops, and
poses no greater risks. Public concern over food allergies in general is also making
it difficult to allay the fears about the safety of GM foods. Public awareness
of food allergies becomes evident during a trip to the grocery store. A label on
a box of instant cake mix warns of an allergy risk because the ingredients
contain wheat and freeze-dried egg. A can of beans provides a similar
precaution because it was prepared with peanut oil.

Investigations of any and all potential food allergy risks associated with GM
food are vital for consumer protection. The US EPA and FDA regulatory
agencies are responding to public fears about GM foods by providing increasingly
close scrutiny of GM-derived commodities. Few traditionally grown foods and
consumer products receive this intensity of inquisition.

Cry9C is a protein in StarLink corn that is being scrutinized as the
potential allergen. This insecticidal protein, produced naturally by
Bacillus thuringiensis subspecies
tolworthi, is a variant of a number of Bt toxins, including the commercially
used Cry1A. Bt toxins work by binding to specific receptors on insect midgut
cells, causing lysis and ultimate decay of the insect's digestive tract. Bt proteins
are host specific and do not bind to vertebrate cells. According to the CDC,
the Cry9C protein shares several molecular properties with proteins that are
known food allergens, which is given as a reason the EPA did not license StarLink
corn for human consumption.

A large number of proteins, as well as other organic compounds,
including complex carbohydrates, terpene-derived compounds, and simple
aromatic molecules, are known to induce allergic reactions. Eggs, milk, peanuts,
soybeans, and wheat lead the list of foods causing allergies in infants and young
children. Adults are more likely to show allergies to crustaceans, eggs,
fish, mollusks, peanuts, tree nuts, and wheat. Researchers working
with the augmentation of these and related compounds in GMO
foods must take into consideration safety concerns and market
resistance to any resulting products intended for human consumption.

The incidence of food allergies in the human population is
low, approximately 1% for adults and 5% for infants. It is
estimated that about 7.5% of the population has reported some type of
food allergy or sensitivity. These data are not conclusive, however,
and percentages may be exaggerated by conditions mimicking
food allergies such as food insensitivities, mild food poisoning,
chemical hypersensitivities, reactions to food additives, and allergic
reactions to molds or pollens.2

In their investigation, the CDC established that 28 of the
people who filed adverse event reports (AERs) with the CDC after
eating corn products containing the Cry9C protein had experienced a
true allergic reaction, unrelated to any other medical condition.
The human allergic response produces IgE antibodies to the
offending antigen, which can be detected in blood serum; consequently,
the CDC initially developed an ELISA test for Cry9C-specific
IgE antibodies. Coded serum samples were analyzed from
three groups of people: the 28 individuals who reported experiencing
an allergic reaction to StarLink; people reported to be highly
sensitive to a large variety of allergens; and historically banked
serum samples collected before Cry9C entered the food supply.
Their study could not confirm a link between Cry9C and the
production of detectable amounts of Cry9C-specific IgE. However, the
CDC report provided a carefully worded conclusion, stating,
"Although our results do not provide any evidence that the allergic
reactions experienced by the people who filed AERs were associated
with hypersensitivity to Cry9C protein, we cannot completely rule
out this possibility, in part because food allergies may occur
without detectable serum IgE to the allergens."

In summary, the CDC did not exhaustively resolve the issue
of allergenicity to Cry9C. The CDC's guarded conclusions still
leave the EPA with the responsibility to decide how to regulate
GMOs containing the Cry9C protein and related compounds, and the
wary public to decide, once again, whether to feel reassured or
apprehensive about eating GM food.

4. Di Serio F, Schöb H, Iglesias A, Tarina C, Bouldoires E,
and Meins F. 2001. Sense- and antisense-mediated gene silencing
in tobacco is inhibited by the same viral suppressors and
is associated with accumulation of small RNAs. Proceedings of
the National Academy of Sciences (USA) 98: 6506-6510.

Although the death of all of the gene-targeted lambs was
a disappointment, this report still was able to show that
gene targeting could be accomplished at two additional
genetic loci. Clearly improvements in the technique for
generating live born lambs after gene targeting and nuclear
transfer are required; however, this report is a cautiously
optimistic first step in being able to precisely modify the genome
of livestock species.

The Grounds of AppealThe appeal lodged proposes that Justice McKay
was incorrect on the following grounds:

 Patent particularsSchmeiser's legal team suggest that, in their
opinion, Justice McKay erred in determining that a farmer
whose field has canola seeds or plants that possess the
genetic modification outlined in Patent 1,313,830 has no right
to grow, cultivate, harvest, or sell any such seeds or
plants, regardless of whether they inadvertently found their
way into the field by adventitious means.

They also state the Judge was incorrect in what
they believe was the determination that a farmer, who knows
or ought to know that there are such GM canola seeds
or plants in his/her crop, will infringe the patent on such a
crop if he saves and reuses canola seed derived from that
crop.

Legal council for Schmeiser holds the belief that the
Judge failed to recognize that, in their opinion, a farmer must
use or take advantage of the patented gene by in-crop
spraying with a glyphosate-based herbicide such as Roundup
in order to infringe the patent on the crop.

They also propose that the Judge was wrong not to
determine that Monsanto had waived their patent rights
by "unleashing" an "invention" into the environment that
it cannot control.

Evidence decisionsIn the appeal documents, Schmeiser's
representatives disagree with the Judge's finding of "no evidence" that
the canola seed planted by Percy Schmeiser in 1997
included seed from a field that had swaths and pollen carried into
it from a neighbor's Roundup Ready canola field.

They also argue that the Judge gave very little weight
to the fact that Monsanto has withdrawn the allegation
that Percy Schmeiser had "obtained" canola seed from one
or more of their licensed users.

In addition to this, Schmeiser's lawyers insist that,
even though Justice McKay found it did not matter
how Schmeiser came into the possession of the patented
seed, the Judge was wrong to put the onus onto Schmeiser
to prove how the seed found its way onto his land, whether
by contamination or otherwise.

TestingSix of the seventeen grounds of appeal submitted on
behalf of Percy Schmeiser challenge the actual testing of crops
on his land. These include assertions that the Judge
gave undue weight and significance to the internal sampling
and testing of the canola by Monsanto and
correspondingly insufficient weight to the independent testing done
on Percy Schmeiser's behalf.

Schmeiser's legal team also disagree with the finding
by the Judge that the samples of the 1998 canola crops
were properly representative of the fields in question, as
there was no expert testimony to support such a finding.

Furthermore, they suggest that the samples from the
1998 canola crop were spoiled and subject to improper
tampering by Monsanto. They strongly believe that such
tests should be dropped as evidence, because the samples
were improperly and/or illegally obtained, which constituted
a possible breach in the correct application of the Charter
of Rights and Freedoms.

 Money, Money, Money .Schmeiser's team also challenge the ruling that
Monsanto, when awarded damages, was entitled to all the
profits made by Schmeiser on his 1998 canola crop,
considering the fact that there was no actual finding of the degree
or extent to which his crop contained the GM Roundup
Ready canola plant.

In addition to this, they are of the opinion that the
Judge was wrong to find that Monsanto was entitled to the
entire net profit of Schmeiser's 1998 canola crop without
proving that the gene that Monsanto claims was present
actually conferred any added commercial value to the crop.

FinallyThe last ground for appeal argues that Justice McKay
was wrong to issue an injunction that Schmeiser's legal
team claim impairs Percy Schmeiser from carrying out
the traditional farming practice of saving and reusing
canola seed during the term of the patent.

The XVIth Congress of Eucarpia will underline the
substantial contribution that Plant Breeding and associated
scientific disciplines will make to improving crop production in
a sustainable way in the 21st century, and covers
every aspect of the science and technology that underpins
the multi-disciplinary and multi-commodity nature of
plant breeding. It has been deliberately structured to
encourage discussion and interaction between delegates.

The program will consist of keynote addresses,
general lectures, specialized seminars, and poster sessions.
A significant part of these sessions will be reserved
for selected oral communications. In addition, there will
be evening round tables to review progress and problems.

Sponsored by the Chinese Government and cosponsored by UNESCO, World Bank, UNDP, and FAO, this conference will provide an opportunity to sum up the achievements and lessons learned in the 20th century, to exchange policies and experience in the development of agricultural science and technology in different countries, and to envision our joint mission of the development in the new century, through innovation and cooperation on agricultural science and technology around the world. The conference is an international gathering, which covers almost all disciplines of agricultural science and technology. It also includes a Governmental Forum and an Agricultural Business Forum.

The material in this News Report is compiled by NBIAP's Information Systems for Biotechnology, a joint project of USDA/CSREES and the Virginia Polytechnic Institute and State University. It does not necessarily reflect the views of the U.S. Department of Agriculture or of Virginia Tech. The News Report may be freely photocopied or otherwise distributed without charge.

ISB welcomes your comments and encourages article submissions. If you have a suitable article relevant to our coverage of the agricultural and environmental applications of genetic engineering, please email it to the Editor for consideration.

To have the News Report automatically emailed to you, send an email message to
news@nbiap.biochem.vt.edu
and type subscribe newsreport [your name] in the message section. Do not include a signature file or additional text. To unsubscribe, send email to news@nbiap.biochem.vt.edu and type unsubscribe newsreport [your name] in the message section, or email isb@vt.edu with your request.
Connect to http://www.isb.vt.edu for internet access to ISB News Reports, textfiles, and databases.